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MM120 · 2 trials · 3 indications
To investigate the dose-response relationship for different doses of MM120 versus placebo in change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 4. The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness.
The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
| Arm | Type | Description |
|---|---|---|
| Arm 1- Placebo | PLACEBO_COMPARATOR | A substance that is designed to have no therapeutic value. |
| Arm 2- 25 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 3- 50 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 4- 100 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 5- 200 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 2- MM120 | EXPERIMENTAL | A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| MM120 | DRUG | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Placebo | OTHER | A substance that is designed to have no therapeutic value. |
Inclusion Criteria: * Bodyweight of ≥ 50 kg * Body mass index \[BMI\] ≥ 18 to ≤ 38 mg/kg2 * Diagnosis of DSM-5 generalized anxiety disorder * Acceptable overall medical condition to be safely enrolled into and to complete the study * Ability to swallow capsules * Ability to provide informed consent...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
MM120 is an investigational small molecule being developed by Definium Therapeutics, Inc. for the treatment of ADHD and Generalized Anxiety Disorder. It is currently in Phase 2 clinical development and has received Breakthrough Therapy designation from the FDA.
MM120 is a small molecule being studied for its effects on ADHD and Generalized Anxiety Disorder. The specific molecular target of MM120 has not been disclosed in available information, so its precise mechanism of action is not publicly detailed.
MM120 is being developed by Definium Therapeutics, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol DFTX.
MM120 is currently in Phase 2 clinical development. It has completed two Phase 2 trials, one for ADHD and one for Generalized Anxiety Disorder, and is not yet approved by the FDA.
MM120 has completed two Phase 2 trials. NCT05200936 studied low-dose MM120 for ADHD in 53 participants across the Netherlands and Switzerland. NCT05407064 was a dose-finding study for anxiety symptoms in 198 participants in the United States.
MM120 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. It has received Breakthrough Therapy designation from the FDA, which is intended to expedite the development and review of drugs for serious conditions.